Alerte De Sécurité sur Commercial Name: BD Vacutainer Plastic Tube with Reagent for Vacuum Blood Collection. Technical name: Vacuum blood collection tube. Registration number ANVISA: 10033430470. Hazard class: I. Model affected: TUBE VACUTAINER CITRATE (9NC) 0,109M TAMPA HEMOGARD 2,7mL. Affected serial numbers: Lots #: 7180812, 7180813, 7180814, 7214941, 7214943, 7305988, 7346905, 7346912 and 8011842.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Becton Dickinson Indústrias Cirúrgicas Ltda; Becton, Dickinson and Company.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Provisions to be adopted by users of the product: 1. Inform all persons in your organization who may be considered users of this product that tubes should be inspected after collection to ensure that an acceptable collection volume has been reached and the Instructions for Use have been observed. The company recommends that you collect the sample again and / or follow the protocols of your institution if the collection volume exceeds 10% of the indicated nominal volume. 2. Complete the attached form and send it to the email so that BD can acknowledge receipt of this notification. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 09/04/2018 - Date of notification notice to Anvisa: 03/05/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Cause
    Increase in the number of reports related to the occurrence of excess blood collection volume for the product vacutainer® citrate (9nc) tube 0.109m hemogard lid 2.7ml., which may compromise coagulation time test results.
  • Action
    Field action code: 21_Abr18, triggered under the responsibility of the company Becton Dickinson Indústrias Cirúrgicas Ltda. Customer Notification